FDA.report

Snowden-Pencer

Primary DI
10885403287459
Brand
Snowden-Pencer
Company
CAREFUSION 2200, INC
Model
SP96-8364
Catalog number
SP96-8364
Device description
Snowden-Pencer MIS ERGONOMIC TAKE-APART IN-LINE CROCODILE GRASPER SA ROTATING, RATCHETED HANDLE 5MM, 36CM, COMPLETE INSTRUMENT
Published
2017-06-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403287459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540328745910885403287459

GMDN Terms

TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags

DUNS number
832696038
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

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00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417888MillenniumAvalign Technologies, Inc.GCJ2026-03-11
B382SD4387110Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD481753PTSTR0Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817570Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817590Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
00198506088964ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089060ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089077ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089084ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
B382SD56534910Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD56740240Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD76500310Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
04251303824985BLUEENDOTROKAMED GmbHGCJ2026-02-27
00198506088704ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088711ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088216ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
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